MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5531G209
Medical Device Problem Codes	Material Erosion (1214); Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Dr (b)(6) from the hospital reported to mr (b)(6), rsm joint replacement the following event: "i had a call from dr (b)(6) on wednesday afternoon for an unusually worn pe x3 triathlon implant.I recovered the implant yesterday and actually there is a big wear for a 1 year bp.
Event or Problem Description
Dr (b)(6) from the hospital reported to mr (b)(6), rsm joint replacement the following event: "i had a call from dr (b)(6) on wednesday afternoon for an unusually worn pe x3 triathlon implant.I recovered the implant yesterday and actually there is a big wear for a 1 year bp.
Additional Manufacturer Narrative
An event regarding wear involving a triathlon insert was reported.The event was confirmed by material analysis of the returned device.Method & results: device evaluation and results: one insert was returned for evaluation.Burnishing, scratching and third-body indentations were observed on the insert condyles these are common damage modes of uhmwpe.A material analysis has been performed.The report concluded: damage was observed on the condyles of the femoral component, consistent with contact against a hard object.Burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Eds analysis showed the femoral component and baseplate were consistent with astm f75 alloy.Biological fixation was observed on the femoral component and baseplate.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #2 9MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7803733
• Report Number: 0002249697-2018-02634
• Device Sequence Number: 16527809
• Product Code: MBH
• UDI-Device Identifier: 07613327045659
• UDI-Public: 07613327045659
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 5531G209
• Device Lot Number: LFN559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention